Units
2.5 QUARTER UNITS
Course Description
This course offers a comprehensive overview of the current European and U.S. Regulatory and Quality Affairs for in vitro diagnostic (IVD) products. You will gain a perspective on the critical elements of the regulatory requirements for obtaining IVD marketing approval. This course will take an extensive look into specific in vitro diagnostics topics and learn about the new and emerging regulatory requirements surrounding them. Learn about the impending transition for IVDs from the current European Directives (IVDD) to new substantially different European Regulations (IVDR), which will bring a majority of currently self-declared IVDs to require Notified Body involvement.
Skills needed: "Quality Systems for Medical Devices: FDA QSR and ISO 13485" or working knowledge/experience in Quality Systems is needed.
Topics
- Intro to IVDs
- IVD Submissions
- IVD Product Development
- Special Categories of IVDs
- Current Topics in IVD Regulatory
- Current Events in IVD Regulation - US and EU
Additional Information
This course will provide students with an understanding of the core elements in the in vitro diagnostic device industry. Topics will include a review of the European and US FDA regulatory frameworks, device classification system, routes to market, pre-market submissions, and post-market surveillance and change requirements. The regulatory approach will address the current requirements, future impending changes and what actions can be taken now to facilitate transitions. Application of quality system requirements as pertinent to IVD devices will also be covered. The course will be interactive, with student participation required, and will consist of lectures and case studies/examples, with three exams and a brief paper with references on a relevant topic of the student’s choice (approved in advance by the instructor).
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